Patient groups welcome release of Draft Intellectual Property Policy

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JOHANNESBURG – On 8 August 2017, the Department of Trade and Industry published the Draft Intellectual Property Policy of the Republic of South Africa, Phase I, 2017. The Fix the Patent Laws Campaign (FTPL) welcomes its publication for public comment.

The FTPL, a coalition of 34 patient advocacy groups, welcomes the clear statements concerning the critical importance of advancing the Constitutionally guaranteed right of access to healthcare services. The policy points the way towards ensuring everyone in South Africa can access the medicines they need. As pointed out in the draft policy, South Africa currently grants many poor quality patents that are rejected in both other developing countries and in developed countries such as the United States. The draft policy shows an encouraging awareness that it is ultimately people in need of medicines and the South African economy that pays the price for our free-for-all patent system.

The draft policy states that the final policy must “first and foremost engender the ethos of the South African Constitution” and that a developmental and rights centred approach to IP is “urgently necessary”. We welcome the government’s commitments to cooperate to achieve the advancement of Constitutional rights and developmental goals and to do so urgently. The inter-departmental coordination between key departments, including Trade and Industry (DTI), Health, Economic Development, International Relations and Cooperation, Science and Technology and Higher Education and Training will be critical to achieving these goals as multiple departments are responsible for the legislation in need of reform. The FTPL will hold all government stakeholders to these commitments.

The draft policy identifies public health as a priority on the basis of important public interest considerations. It indicates that the DTI, together with key government departments, intends to address substantively in the immediate term, access to medicines, vaccines and diagnostics and South Africa’s approach to international IP cooperation. This policy and law reform process could thus be an important constitutional measure “to achieve the progressive realisation” of the right to health.

We welcome the DTI’s engagement with the United Nations Secretary General’s High-Level Panel on Access to Medicines report, which makes important recommendations about what states can do to ensure greater access to medicines, particularly through patent law reform.

We thank the DTI for taking account of the submissions made in respect of the IP Consultative Framework and for the substantive detail contained in this draft policy. The FTPL will study the draft policy and make comprehensive comments to assist the DTI and its government partners to implement the reforms in line with their constitutional obligations.

The following are preliminary views on the draft policy:

We support the implementation of a system of substantive search and examination of patent applications in order to ensure compliance with existing law and to ensure that only applications deserving of patent protection are granted. We agree with the proposed incremental approach, which we submit can be achieved by starting with the pharmaceutical sector and by considering outsourcing of the examination of applications for patents.

We support the recommendation to introduce pre- and post-grant opposition procedures in our law. We agree that such procedures are beneficial in that they ensure that the patent examiner has access to relevant information concerning the patent application. Third parties, which could include generic companies and civil society groups, will be able to assist the patent examiner in the decision-making process. We encourage an administratively cost-effective procedure and wide access to information concerning patent applications to enable third parties to intervene. We will make detailed submissions on potential interim procedures to enable such interventions as early as possible.

We welcome the commitment to develop patentability criteria in line with the state’s “constitutional obligations, developmental goals and public policy priorities” as well as the intention to utilise available flexibilities to strike the correct balance between promoting innovation and protecting the rights of IP holders and users (patients). We hope that this stated intention will lead to fewer poor quality or ever-greening patents being granted in South Africa and that instead only true innovations will be rewarded with patent protection.

We support the recommendations to introduce non-judicial, cost effective and expeditious mechanisms to obtain medicines through the issuance of compulsory licences. In this regard, we support the recommendation to remove the requirement that a government department first negotiates terms of a licence before approaching a court to seek a compulsory licence. This is not required by the TRIPS Agreement and should be removed through the necessary amendments to the Patents Act.

Unlike countries like Argentina, Brazil and India, South Africa has to date not taken sufficient advantage of the public health flexibilities available to it in international law in order to promote public health. This draft policy provides an opportunity that should not be squandered. It has taken 20 years of stalled policy processes to get to this point. If South Africa wishes to lead on this issue, as is expressed in the policy, the policy must be finalised with the necessary urgency and draft bills must be published with equal urgency so that the people can directly benefit from greater access to medicines for cancer, tuberculosis, HIV, mental health conditions, hepatitis, epilepsy, and many other diseases.

Many people in South Africa continue to die and suffer because they cannot access the medicines that they need. This policy provides hope to those people. It is now up to the government to deliver on this promise by swiftly implementing wide-ranging law reform in line with this policy.

The FTPL will publicly share its submission and its full views on the draft policy. We encourage other stakeholders to publicly state their positions on the proposals in the draft policy. Comments are open for 60 days from the date of publication of the draft policy in the Government Gazette.